A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.

NCT ID: NCT00462384

Last Updated: 2016-04-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-04-30

Brief Summary

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram [mcg/kg]). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions

Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methoxy Polyethylene Glycol-epoetin Beta

Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.

Group Type: EXPERIMENTAL

Methoxy Polyethylene Glycol-epoetin Beta

Intervention Type: DRUG

Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.

Interventions

Methoxy Polyethylene Glycol-epoetin Beta

Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.

Intervention Type: DRUG

Other Intervention Names

Mircera; RO0503821

Eligibility Criteria

Inclusion Criteria

• chronic kidney disease, stage 3 or 4;
• anemia (baseline hemoglobin between 9 and 11 grams per deciliter [g/dL]).

Exclusion Criteria

• previous therapy with ESA within 12 weeks prior to screening;
• significant acute or chronic bleeding such as overt gastrointestinal bleeding;
• red blood cell transfusions within 8 weeks before screening;
• active malignant disease (except non-melanoma skin cancer).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Tallinn, , Estonia

Tallinn, , Estonia

Tartu, , Estonia

HUS, , Finland

Joensuu, , Finland

Jyväskylä, , Finland

Kajaani, , Finland

Kotka, , Finland

Porvoo, , Finland

Tampere, , Finland

Turku, , Finland

Jūrmala, , Latvia

Liepāja, , Latvia

Riga, , Latvia

Riga, , Latvia

Valmiera, , Latvia

Ventspils, , Latvia

Hønefoss, , Norway

Lillehammer, , Norway

Oslo, , Norway

Stavanger, , Norway

Trondheim, , Norway

Countries

Estonia; Finland; Latvia; Norway

Other Identifiers

ML20659

Identifier Type: -

Identifier Source: org_study_id